Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

Forms and Documents

Document Name	Status
Form 1 PRS Account Form and Instruction	Modified
Form 1 Basic Results Information (All Categories) Form and Instruction	Removed
Form 1 Device - Voluntary Newly Registered Trials Form and Instruction	Removed
Form 1 Device - Mandatory Newly Registered Trials Form and Instruction	Removed
Form 1 Drug and Biologic - Voluntary Newly Registered Trials Form and Instruction	Removed
Form 4 Extension Request Form and Instruction	Modified
Form 3 Certification to Delay Results Form and Instruction	Modified
Form 2 Result Submission Updates Form and Instruction	Modified
Form 2 Initial Results Submission Form and Instruction	Modified
Form 1 Registration Updates Form and Instruction	Modified
Form 1 Initial Registration Form and Instruction	Modified
Attachment 5 - Privacy Act Review _Clinical Trials gov Extension 2015.doc Supplementary Document	2015-08-28
Attachment 2 - ClinicalTrials.gov Protocol Data Element Definitions.pdf Supplementary Document	2015-08-28
Attachment 1 - ClinicalTrials.gov Basic Results Data Element Definitions.pdf Supplementary Document	2015-08-28
NLM Clinical Trials ICR Supporting Statement August 2015 (2).docx Supporting Statement A	2015-08-28

IC Document Collections

IC ID	Document Title	Status
6153	PRS Account Form and Instruction	Modified
202116	Basic Results Information (All Categories) Form and Instruction	Removed
185105	Device - Voluntary Newly Registered Trials Form and Instruction	Removed
185104	Device - Mandatory Newly Registered Trials Form and Instruction	Removed
185103	Drug and Biologic - Voluntary Newly Registered Trials Form and Instruction	Removed
185102	Extension Request Form and Instruction	Modified
185097	Certification to Delay Results Form and Instruction	Modified
185096	Result Submission Updates Form and Instruction	Modified
185095	Initial Results Submission Form and Instruction	Modified
185094	Registration Updates Form and Instruction	Modified
185093	Initial Registration Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0586	ICR Reference No: 201508-0925-001
Status: Historical Active	Previous ICR Reference No: 201204-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/25/2015
	Date Received in OIRA: 08/28/2015
Terms of Clearance: Approved consistent with previous terms of clearance: This collection is approved consistent with the agreement that NIH will continue to work with OMB and other interested agencies as they move forward with the rule making process that will eventually define the adverse event reporting framework in response to U.S. Public Law 110-85 (i.e., determining the best method for including in the registry and results databank appropriate results information on serious adverse and frequent adverse events.) These terms of clearance do not preclude the option of NIH using the FDAAA default as a starting point for adverse event reporting. OMB understands that NIH will seek public comments through rulemaking and incorporate prior experience with the optional reporting system to ensure that the default elements are incorporated and displayed in an appropriate and meaningful way

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2018	36 Months From Approved	11/30/2015
Responses	224,530	0	168,390
Time Burden (Hours)	682,535	0	474,873
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request seeks an extension of the existing Paperwork Reduction Act clearance for the collection of clinical trial registration and results information via the ClinicalTrials.gov web site operated by the National Library of Medicine (NLM) under the authority of the Director, National Institutes of Health (NIH). The Office of Management and Budget (OMB) Notice-of-Action authorizing the current 3-year approval of the information collection (OMB No. 0925-0586) was issued August 20, 2012 and is due to expire on August 31, 2015. The purpose of the clinical trials registry data bank is to enhance patient enrollment and provide a mechanism to track the progress of clinical trials. The information is intended to provide current and reliable information on the broadest possible scale to members of the public, including to physicians and researchers, about the existence, nature, enrollment status, location, eligibility criteria, sponsorship and progress of clinical trials.

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Authorizing Statute(s): PL: Pub.L. 105 - 115 113 Name of Law: FDAMA
   PL: Pub.L. 110 - 85 801 Name of Law: FDA Act of 2007
   US Code: 42 USC 282(j) Name of Law: Expanded Clinical Trial Registry Databank
   US Code: 42 USC 282(i) Name of Law: None
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 32968	06/10/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 50297	08/19/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Result Submission Updates	2	ClinicalTrials.gov Results Reporting Data Entry Screen Shots
Certification to Delay Results	3	Certification Form
Extension Request	4	Extension Request
Basic Results Information (All Categories)	1	Reporting Data Entry
Device - Voluntary Newly Registered Trials	1	Registration Data Entry
Device - Mandatory Newly Registered Trials	1	Registration Data Entry
Registration Updates	1	Registration Data Entry
PRS Account	1	ClinicalTrials.gov Registration Data Entry Screen Shots
Initial Results Submission	2	ClinicalTrials.gov Results Reporting Data Entry Screen Shots
Initial Registration	1	ClinicalTrials.gov Registration Data Entry Screen Shots
Drug and Biologic - Voluntary Newly Registered Trials	1	Registration Data Entry

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	224,530	168,390	0	111,130	-54,990	0
Annual Time Burden (Hours)	682,535	474,873	0	376,735	-169,073	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Forms

Short Statement: This supporting statement includes an adjustment to the burden estimates to reflect recent growth in the number of studies for which registration and results information are submitted on an annual basis to ClinicalTrials.gov. The result is an increased annual burden estimated for registration of 138,000 hours above the previous information collection and an increased estimated annual burden of 74,000 hours for the submission of results information. Much of this increase results from the voluntary use of ClinicalTrials.gov for registration and results submission by those who conduct clinical studies.

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Annual Cost to Federal Government: $4,826,307

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 08/28/2015

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